Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument

Pulmonary Arterial Hypertension Clinical Trial

— SYMPHONYext  

Official title:

AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01847014
• Other study ID #: AC-055-402
• Status: Terminated
• Phase: Phase 3
• Start date: September 1, 2013
• Est. completion date: November 30, 2017

Study information

• Verified date: June 2018
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 30, 2017
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure.

• Patients with PAH who completed study AC-055-401

• Women of childbearing potential must:

• Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.

• Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Exclusion Criteria:

• Patients who prematurely discontinued study drug in study AC-055-401

• Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study

• Known hypersensitivity to macitentan or its excipients or drugs of the same class

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Macitentan
Macitentan tablet, dose of 10 mg, once daily.

Locations

Country	Name	City	State
United States	The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital	Cincinnati	Ohio
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident Rate of Adverse Events (AEs).	Safety events are reported and documented as defined in study protocol from baseline to end of treatment period including safety follow-up visit.	From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).